Trial Outcomes & Findings for DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients. (NCT NCT00478933)

NCT ID: NCT00478933

Last Updated: 2025-07-02

Results Overview

The GNAS c.393C\>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia \<400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias \<400 msec were tracked by genotype.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1223 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2025-07-02

Participant Flow

Participant milestones

Measure	ICD Therapy, Blood Sampling Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes. Blood sampling: Blood sampling for genetic analysis of the pre-identified SNPs
Overall Study STARTED	1223
Overall Study COMPLETED	1145
Overall Study NOT COMPLETED	78

Reasons for withdrawal

Measure	ICD Therapy, Blood Sampling Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes. Blood sampling: Blood sampling for genetic analysis of the pre-identified SNPs
Overall Study Protocol Violation	22
Overall Study Informed consent not verified	3
Overall Study Inadequate data available	53

Baseline Characteristics

DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.

Baseline characteristics by cohort

Measure	ICD Therapy, Blood Sampling n=1198 Participants Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes. Blood sampling: Blood sampling for genetic analysis on pre-specified SNPs
Age, Continuous	61.7 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	194 Participants n=5 Participants
Sex: Female, Male Male	1004 Participants n=5 Participants
Region of Enrollment Austria	40 participants n=5 Participants
Region of Enrollment Denmark	57 participants n=5 Participants
Region of Enrollment Spain	189 participants n=5 Participants
Region of Enrollment Finland	25 participants n=5 Participants
Region of Enrollment France	84 participants n=5 Participants
Region of Enrollment Germany	491 participants n=5 Participants
Region of Enrollment Greece	26 participants n=5 Participants
Region of Enrollment Hungary	59 participants n=5 Participants
Region of Enrollment Italy	54 participants n=5 Participants
Region of Enrollment Norway	26 participants n=5 Participants
Region of Enrollment Poland	134 participants n=5 Participants
Region of Enrollment United Kingdom	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

The GNAS c.393C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.

Outcome measures

Measure	c.393C>T CC Genotype n=285 Participants Patients in this group have two copies of the major (C) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T CT Genotype n=555 Participants Patients in this group have one copy of each allele (C and T) for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T TT Genotype n=305 Participants Patients in this group have two copies of the minor (T) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype	63 participants with VT < 400 msec	136 participants with VT < 400 msec	98 participants with VT < 400 msec

PRIMARY outcome

Timeframe: 2 years

The GNAS c.2273C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.

Outcome measures

Measure	c.393C>T CC Genotype n=456 Participants Patients in this group have two copies of the major (C) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T CT Genotype n=533 Participants Patients in this group have one copy of each allele (C and T) for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T TT Genotype n=156 Participants Patients in this group have two copies of the minor (T) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2273C>T Genotype	103 participants with VT < 400 msec	136 participants with VT < 400 msec	59 participants with VT < 400 msec

PRIMARY outcome

Timeframe: 2 years

The GNAS c.2291C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.

Outcome measures

Measure	c.393C>T CC Genotype n=527 Participants Patients in this group have two copies of the major (C) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T CT Genotype n=508 Participants Patients in this group have one copy of each allele (C and T) for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T TT Genotype n=110 Participants Patients in this group have two copies of the minor (T) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2291C>T Genotype	145 participants with VT < 400 msec	123 participants with VT < 400 msec	29 participants with VT < 400 msec

PRIMARY outcome

Timeframe: 2 years

The GNAQ c.-909/-908GC>TT single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.

Outcome measures

Measure	c.393C>T CC Genotype n=342 Participants Patients in this group have two copies of the major (C) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T CT Genotype n=546 Participants Patients in this group have one copy of each allele (C and T) for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T TT Genotype n=257 Participants Patients in this group have two copies of the minor (T) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-909/-908GC>TT Genotype	85 participants with VT < 400 msec	143 participants with VT < 400 msec	69 participants with VT < 400 msec

PRIMARY outcome

Timeframe: 2 years

The GNAQ c.-382G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.

Outcome measures

Measure	c.393C>T CC Genotype n=945 Participants Patients in this group have two copies of the major (C) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T CT Genotype n=189 Participants Patients in this group have one copy of each allele (C and T) for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T TT Genotype n=11 Participants Patients in this group have two copies of the minor (T) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-382G>A Genotype	253 participants with VT < 400 msec	42 participants with VT < 400 msec	2 participants with VT < 400 msec

PRIMARY outcome

Timeframe: 2 years

The GNAQ c.-387G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.

Outcome measures

Measure	c.393C>T CC Genotype n=1041 Participants Patients in this group have two copies of the major (C) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T CT Genotype n=101 Participants Patients in this group have one copy of each allele (C and T) for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T TT Genotype n=3 Participants Patients in this group have two copies of the minor (T) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene
Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-387G>A Genotype	268 participants with VT < 400 msec	29 participants with VT < 400 msec	0 participants with VT < 400 msec

PRIMARY outcome

Timeframe: 2 years

The GNB3 c.825C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.

Outcome measures

Measure	c.393C>T CC Genotype n=536 Participants Patients in this group have two copies of the major (C) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T CT Genotype n=499 Participants Patients in this group have one copy of each allele (C and T) for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene	c.393C>T TT Genotype n=110 Participants Patients in this group have two copies of the minor (T) allele for the c.393C\>T single nucleotide polymorphism (SNP) in the GNAS gene
Outcome Measure Title: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNB3 c.825C>T Genotype	135 participants with VT < 400 msec	136 participants with VT < 400 msec	26 participants with VT < 400 msec

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

Adverse Events

ICD Therapy, Blood Sampling

Serious events: 265 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	ICD Therapy, Blood Sampling n=1145 participants at risk Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes. Blood sampling: Blood sampling for genetic analysis on pre-identified SNPs
General disorders Implant site pain	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Surgical and medical procedures Abdominal operation	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders Acute coronary syndrome	0.26% 3/1145 • Number of events 3 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Renal and urinary disorders Acute kidney injury	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders Acute myocardial infarction	0.17% 2/1145 • Number of events 3 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Blood and lymphatic system disorders aneamia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders angina pectoris	0.44% 5/1145 • Number of events 8 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Vascular disorders aortic aneurysm	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders arrhythmia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders arrhythmia supraventricular	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Investigations arteriogram coronary	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders asthenia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders atrial fibrillation	0.96% 11/1145 • Number of events 13 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders atrial flutter	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders atrial tachycardia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Musculoskeletal and connective tissue disorders back pain	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Hepatobiliary disorders bile duct stone	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders bradyarrhythmia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Surgical and medical procedures cardiac ablation	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders cardiac failure	2.4% 27/1145 • Number of events 31 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders cardiac failure acute	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders cardiac failure chronic	0.26% 3/1145 • Number of events 3 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders cardiac tamponade	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders cardiogenic shock	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Surgical and medical procedures cardioversion	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders cerebellar stroke	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders cerebral infarction	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders cerebrovascular accident	0.26% 3/1145 • Number of events 3 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders chest discomfort	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders chest pain	0.35% 4/1145 • Number of events 4 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Hepatobiliary disorders Cholecystitis chronic	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.26% 3/1145 • Number of events 3 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Vascular disorders circulatory collapse	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) colon cancer metastatic	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders Complication associated with device	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders cororary artery disease	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders cough	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders death	0.26% 3/1145 • Number of events 3 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Vascular disorders deep venous thrombosis	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Metabolism and nutrition disorders dehydration	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues device dislocation	0.17% 2/1145 • Number of events 3 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues Device electrical impedance issue	0.79% 9/1145 • Number of events 9 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues device extrusion	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues device issue	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues device lead damage	0.17% 2/1145 • Number of events 2 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues device lead issue	0.26% 3/1145 • Number of events 3 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues device malfunction	0.44% 5/1145 • Number of events 5 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues device pacing issue	0.26% 3/1145 • Number of events 4 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Infections and infestations device related infection	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues device stimulation issue	0.17% 2/1145 • Number of events 2 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders dizziness	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders dyspnoea	0.44% 5/1145 • Number of events 6 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders dyspnoea exertional	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Gastrointestinal disorders gastrointestinal haemorrhage	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Gastrointestinal disorders gastrointestinal uler haemorrhage	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders General physical health deterioration	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Metabolism and nutrition disorders gout	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Vascular disorders haematoma	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Vascular disorders haemorrhage	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders heart failure	0.26% 3/1145 • Number of events 3 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Surgical and medical procedures hospitalisation	0.26% 3/1145 • Number of events 4 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders hypertension	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Renal and urinary disorders hypertensive nephropathy	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Endocrine disorders hyperthyroidism	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Metabolism and nutrition disorders hypokalaemia	0.17% 2/1145 • Number of events 2 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders ill-defined disorder	0.17% 2/1145 • Number of events 2 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders implant site haematoma	0.44% 5/1145 • Number of events 5 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Injury, poisoning and procedural complications implant site infection	0.61% 7/1145 • Number of events 7 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Infections and infestations implant site infection	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders implant site swelling	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders implant site ulcer	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Investigations inflammatory marker increased	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Musculoskeletal and connective tissue disorders invertebral disc protrusion	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Blood and lymphatic system disorders iron deficiency anaemia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders ischaemic cardiomayopathy	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders ischaemic stroke	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues lead dislodgement	1.7% 20/1145 • Number of events 21 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Infections and infestations lung infection	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Infections and infestations medical device site abscess	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders Medical device site extravasation	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Injury, poisoning and procedural complications multiple injuries	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders Multiple organ dysfunction syndrome	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Musculoskeletal and connective tissue disorders myalgia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders myocardial infarction	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Infections and infestations opthalmic herpes simplex	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders orthopnea	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Reproductive system and breast disorders ovarian cyst	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues oversensing	0.44% 5/1145 • Number of events 5 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders Pacemaker generated arrhythmia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders pain	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Musculoskeletal and connective tissue disorders pain in extremity	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders palpitations	0.26% 3/1145 • Number of events 3 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders paroxysmal arrhythmia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Surgical and medical procedures Peripheral artery stent insertion	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Vascular disorders peripheral artery thrombosis	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Infections and infestations pneumonia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders pneumothorax	0.61% 7/1145 • Number of events 7 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Injury, poisoning and procedural complications pocket erosion	0.17% 2/1145 • Number of events 2 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders presyncope	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders pulmonary oedema	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Renal and urinary disorders renal failure	0.26% 3/1145 • Number of events 4 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders silent myocardial infarction	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) small cell lung cancer	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Surgical and medical procedures stent placement	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders supraventricular extrasystoles	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders therapy non-responder	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Vascular disorders thrombosis	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders transient global amnesia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Injury, poisoning and procedural complications traumatic haemothorax	0.09% 1/1145 • Number of events 2 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues undersensing	0.61% 7/1145 • Number of events 7 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Infections and infestations urinary tract infection bacterial	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Vascular disorders vena cava thrombosis	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders ventricular arrhythmia	0.35% 4/1145 • Number of events 4 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders ventricular fibrillation	0.52% 6/1145 • Number of events 6 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders ventricular tachycardia	0.70% 8/1145 • Number of events 9 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Injury, poisoning and procedural complications wound necrosis	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.

Other adverse events

Measure	ICD Therapy, Blood Sampling n=1145 participants at risk Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes. Blood sampling: Blood sampling for genetic analysis on pre-identified SNPs
Infections and infestations abscess	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders acute coronary syndrome	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Gastrointestinal disorders acute haemorrhagic ulcerative colitis	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Injury, poisoning and procedural complications alcohol poisoning	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders atrial fibrillation	0.26% 3/1145 • Number of events 3 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders cardiac death	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders cardiac failure	0.17% 2/1145 • Number of events 2 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders cardiac failure acute	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders cardiac tamponade	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders carpal tunnel syndrome	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders cerebrovascular accident	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders chest pain	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Psychiatric disorders depression	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Product Issues device extrusion	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders dizziness	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders dyspnoea	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders emphysema	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Injury, poisoning and procedural complications fall	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Surgical and medical procedures hospitalisation	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Vascular disorders hypertensive emergency	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Vascular disorders hypotension	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders implant site haematoma	0.09% 1/1145 • Number of events 2 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Injury, poisoning and procedural complications implant site infection	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Infections and infestations implant site infection	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders implant site pain	0.17% 2/1145 • Number of events 2 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders malaise	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
General disorders Medical device site haematoma	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Infections and infestations pneumonia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders pneumothorax	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders presyncope	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Musculoskeletal and connective tissue disorders rotator cuff syndrome	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Nervous system disorders sciatica	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Infections and infestations sepsis	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders sinus tachycardia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Respiratory, thoracic and mediastinal disorders sleep apnoea syndrome	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Musculoskeletal and connective tissue disorders spinal pain	0.09% 1/1145 • Number of events 2 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders supraventricular tachycardia	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Cardiac disorders ventricular tachycardia	0.17% 2/1145 • Number of events 2 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Injury, poisoning and procedural complications wound secretion	0.09% 1/1145 • Number of events 1 • From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported. Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.

Additional Information

Margriet Kruijshoop, Clinical Research Manager

Medtronic BRC

Phone: +31623910708

Email: margriet.kruijshoop@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60